MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	305272
Medical Device Problem Codes	Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb leaked and had the needle retract prematurely.The following information was provided by the initial reporter: "it was reported that while administering medication to patient, needle retracted prior to finishing the injection.It was also reported that while giving another injection, medicine leaked out of where the syringe and needle attach.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-07-20.H6: investigation summary four 3ml integra syringes (p/n 305272) in sealed blisterpaks from batch #0002379 were received.The samples were visually evaluated and functionally tested.There were no visible defects on the syringe, or damage to the collar or tip area that would inhibit a connection.Additionally, all readings for plunger rod collapse and hub cut were within specification after testing.The instructions for use state: "attach the bd integra retracting precisionglide needle firmly onto the bd integra syringe with a push and a clockwise twist" prior to use.It is unclear if this was done prior to usage.Since no samples displaying the reported conditions were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb leaked and had the needle retract prematurely.The following information was provided by the initial reporter: " it was reported that while administering medication to patient, needle retracted prior to finishing the injection.It was also reported that while giving another injection, medicine leaked out of where the syringe and needle attach.".

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12236156
• Report Number: 1213809-2021-00518
• Device Sequence Number: 3718882
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: 0002379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1